Having worked in sterile production environments where contamination control was vital, there were zero exceptions to following the established procedures. Exceptions would invariably lead to unacceptable outcomes. With regards to lock-down and quarantine in relation to SARS-COV-2, there are many exceptions and deviations from the requirements. That will only lead to….you guessed it, an unacceptable outcome. With this in mind, I present to you a brief article on contamination control in sterile production environments.
What Is Contamination Control
This is the prevention of contamination of an environment with particles (viable or not) and the prevention of cross contamination (Product A getting into Product B or an excipient getting into the wrong product). Therefore, contamination control is concerned with both microbial contamination and physical contamination.
The Need to Control Contamination
- Contaminated products could lead to end user death.
- Contaminated products cost time and money while an investigation is conducted.
- False positives in testing cost time and money while an investigation is conducted and retraining is conducted.
- Contamination can lead to an adulterated product.
- Contaminated product potentially needs destruction.
Reducing Contamination Risk by Controlling Contamination
In sterile production facilities, reducing the risk contamination (and cross contamination) is a high priority. In order to reduce the risk of introducing or spreading contamination the following is necessary:
- Validate your process.
- Validate your materials.
- Use approved materials.
- Training of staff.
- Use approved processes.
- Thoroughly clean the production environment between batches.
- Thoroughly carry out line clearances.
- Monitor the environment to ensure sterility is maintained.
- Make no exceptions.
This discussion will focus on the sterile production environment.
Reasons Contamination Control is Vital
From a business perspective, a failure to prevent contamination costs time and money.
You need to put the batch on hold, investigate the deviation, implement corrective and preventative actions, retrain staff, review and potentially update documentation, potentially notify the regulatory body, potentially pay non delivery fines, potentially discard the batch. Failure to do what is required above could lead to business failure.
From an end user perspective, contamination in a product might cause it to be ineffective, might cause an adverse effect, and might cause death. An ineffective product is an annoyance. A lethal product is bad for the end user and could lead to a failure of your business through recalls, fines, trade restrictions or other.
One example of not following established procedures would be to allow person into a clean room wearing a homemade mask rather than the proscribed surgical mask. This is because the surgical mask (presumably) has been validated for efficacy in contributing to protecting the product from the individual wearing it. To do so would represent an unacceptable risk to the sterility of you processes. If an auditor discovered such a procedural deviation, you would be cited.
Ensuring Your Adequate Contamination Control Is Adequate
Staff need the education, training and experience necessary to do their job effectively. You must ensure those following procedures are trained in and signed off on these procedures, know why the procedures are in place and they follow the procedures.
You cannot assume those that are trained will follow the procedures, you must monitor your processes to ensure those performing them are doing so correctly. A retraining and recertification schedule might be useful here. Ongoing viable environmental monitoring, systems monitoring and particle monitoring are an important part of ensuring your contamination control (or state of control) is maintained. Such processes can provide indication when control is slipping allowing you to take corrective action before something goes out of specification.
The Risks Of Failing To Ensure Adequate Contamination Control
- Your business fails.
- You kill your customers.
Not having suitable contamination control procedures in place, or having such procedures and not following them or making exceptions leads to contamination. This is undesirable for both your business and your end user.
- PIC/S 009-14 Chapter 1 – Pharmaceutical Quality System – Quality Risk Management
- PIC/S 009-14 Chapter 2 – Personnel
- PIC/S 009-14 Chapter 5 – Production – Prevention of Cross-contamination in Production
- PIC/S 009-14 Chapter 6 – Quality Control
A Side Note – Efficacy of masks.
I always understood that masks were meant to protect product not the individual. Being interested in such matters, from time to time I conduct literature searches into the efficacy of surgical masks. Time and again minimal study results are returned. This suggests that interest in the topic is low. Perhaps that will change with the 2020 Coronavirus pandemic.
In a production environments where the product was toxic, in addition to face masks (to protect the product) we would use rebreathers (to protect the individual). When handling highly toxic or infection agents, a self-contained suit with its own air supply would be used to protect the individual. This indicates a (surgical) mask is not adequate protection from airborne contaminates.
As for a production environment, if the mask is not work correctly (typically due to a lack of training, education and experience to wear it properly), the effectiveness of the mask will be reduced.
A Side Note – Restriction of Movement
A regulatory guideline is a requirement for detailed hygiene programs to monitor the health, hygiene practices and clothing of your staff. Staff cannot enter controlled areas when they are sick, demonstrating poor hygiene or not wearing approved clothing. This is because even when fully gowned up in such a way that is intended to reduce the risk of product contamination, individuals who are ill, practice poor hygiene or are wearing the incorrect attire pose an unacceptable and increased risk to the safely of your product.
If you were to apply this approach outside of a sterile production environment, say in the community, those who are ill would not be allowed to circulate in the general population. As in all cases, a risk based approach is taken.
- How likely is a sick person to infect another? Can we mitigate this risk?
- What the consequences are of allowing the individual to circulate – do the rights of the individual outweigh the rights of, or the risks to the larger population?
- Does the individual potentially causing the death of another an represent an acceptable risk?
- What are the consequences of not allowing the individual to circulate – do the risks to the general population outweigh the rights of the individual?
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